TRANSCOMP
Comparison of Endotracheal Tube Surface Electrodes and Transcartilage Needle Electrodes for Intraoperative Neuromonitoring During Thyroidectomy: A Prospective Within-Patient Comparison
Sponsor study identifier
interventional
100
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroidectomy is most commonly performed with surface electrodes embedded in the endotracheal tube (ETT). ETT electrodes are prone to malposition, rotation and secretions, which can produce low signal amplitudes and false signal loss. Transcartilage needle electrodes (TCN), placed into the thyroid cartilage, have been reported to yield higher and more stable amplitudes. This single-center prospective study records ETT and TCN signals simultaneously in the same patient during thyroidectomy, so that each patient serves as their own control. The primary aim is to compare how often each electrode type shows a false amplitude decrease of more than 50% in nerves without true injury. Voice and swallowing outcomes are assessed before surgery and at 2 weeks and 3 months after surgery using the Turkish versions of the Voice Handicap Index-10 and the Eating Assessment Tool-10.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2026
Actual (reported)October 28, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rate of false amplitude decrease greater than 50%
Proportion of evaluations in which the amplitude at vagal stimulation after resection (V2) is more than 50% lower than the amplitude at vagal stimulation before resection (V1), among nerves in which no true nerve injury is present. One nerve per patient is analyzed, on the first side evaluated, and the two electrode types are compared within the same nerve using the two-sided exact McNemar test. True nerve injury is determined by a combination of a standard loss-of-signal algorithm, intraoperative findings and, where indicated, postoperative laryngoscopy performed within 2 weeks after surgery.
Intraoperative recording (up to 4 hours), with true nerve injury status ascertained by postoperative laryngoscopy within 2 weeks after surgery
Proportion of evaluations with a baseline amplitude of 500 microvolts or more at vagal stimulation before resection (V1)
Intraoperative, before resection (up to 2 hours)
All participants undergo thyroidectomy with simultaneous recording from an endotracheal tube surface electrode and transcartilage needle electrodes. Each participant serves as their own control.
Paired needle electrodes are inserted into the anterior thyroid cartilage in the subperichondrial plane through the existing neck incision at the start of the operation, and removed at the end. Electromyographic responses to vagal and recurrent laryngeal nerve stimulation are recorded at vagal stimulation before dissection (V1), recurrent laryngeal nerve stimulation after identification (R1), recurrent laryngeal nerve stimulation after completion of lobar dissection (R2) and vagal stimulation at the end of the procedure (V2).
Marmara University School of Medicine Hospital, Department of General Surgery
Istanbul, 34854, Turkey (Türkiye)
First Submitted
October 20, 2026
First Posted
October 28, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of evaluations in which the final amplitude is unchanged or higher than baseline
Intraoperative, up to 4 hours
Signal amplitude in microvolts at each stimulation step
Intraoperative, up to 4 hours
Signal latency in milliseconds at each stimulation step
Intraoperative, up to 4 hours
Rate of technical failure, defined as failure to obtain a baseline signal
Intraoperative, before resection (up to 2 hours)
A standard neuromonitoring endotracheal tube with surface electrodes is positioned at intubation. Electromyographic responses to vagal and recurrent laryngeal nerve stimulation are recorded at the same four stimulation steps, simultaneously with the needle electrode channel.
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Primary Completion
July 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
Individual participant data are not planned to be shared.
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Source: ClinicalTrials.gov.
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